Neurosurgeon and Bioengineer Aim for Paradigm Shift in Treatment of Hydrocephalus
“We threw out the current system design and started from scratch, we needed to look at Hydrocephalus as if it was a new problem we could solve with modern technology.”Samuel Browd, Neurosurgeon at Seattle Children’s Hospital and Harborview Medical Center
Advances in medical technology and surgical techniques have dramatically improved diagnosis and treatment of most disorders, saving and extending lives. Yet the technology revolution has bypassed a simple device used for 50 years to treat a relatively common but devastating condition in newborns — hydrocephalus, the excess accumulation of cerebrospinal fluid in the brain. If this fluid is not continuously drained through a catheter and shunt system, the pressure buildup can damage brain tissue and expand the skull bones leading to fatal consequences.
Shunts are normally required for the entire life of the patient. The best shunt design still fails with high frequency: 30 percent fail within one year of the initial surgery, and virtually 100 percent fail within ten years, usually due to clogging and infection. Shunt failure is a life-threatening emergency requiring surgical replacement, and it accounts for half of all pediatric neurosurgery cases and $3 billion a year in health care expenditures.
“Those are heartbreaking numbers,” said Samuel Browd, an attending neurosurgeon at Seattle Children’s Hospital, and at UW and Harborview medical centers. “Hydrocephalus has been treated as a plumbing problem, but it’s much more complex, and all pediatric neurosurgeons are frustrated with the lack of significant advances in shunt technology.”
Redesigning from Scratch
Browd took his frustration to the UW Department of Bioengineering in late 2009, where he found an enthusiastic collaborator in Barry Lutz, a professor and researcher with expertise in microfluidic devices and point-of-care diagnostics.
“We threw out the current system design and started from scratch,” Browd said. “We needed to look at hydrocephalus as if it was a new problem we could solve with modern technology.”
“Sam invited me over to Children’s Hospital to observe a surgery on a two-year-old girl,” Lutz said. “She had had a dozen previous surgeries. The stress on parents is enormous, because they have no way to tell if a child’s illness is just a minor problem or an issue with the shunt, and every surgery carries a five to ten percent risk of infection and potential for brain damage. I left Children’s committed to working with Sam to improve the technology.”
The device Browd and Lutz developed is simple in mechanics and fluidics. Its inventors envision two stages of development. The first is a “smart” external shunt that could be used for diagnostics and for short-term treatment of patients with infections, stroke, hemorrhage, brain tumors, and hydrocephalus caused by trauma. It automatically maintains the drainage rate of cerebrospinal fluid and eliminates the need for frequent adjustments by nurses. Patients will no longer have to remain completely still during treatment but can move about freely. The device will be safer for patients and improve monitoring efficiency. Browd and Lutz hope this initial product can reach the market within two years.
The next goal is the development of a more advanced electronic shunt for internal implantation that will allow physicians to diagnose buildup of intracranial pressure from excess fluid. It will be more readily adjustable to the patient’s physiology to avoid clogging and infection. This approach will help reduce the need for CT scans to diagnose shunt failure, which can increase risk of cancer in patients who require repeated scans. These features should greatly improve the quality of life for children and adult patients, and reduce health care expenditures for hydrocephalus. Testing, refining, and clinical trials probably mean a new device will reach the market in five years.
Enlisting C4C Expertise
This is Browd and Lutz’s first effort to develop a medical device. UW Center for Commercialization (C4C) technology manager Valerie Carricaburu, serving as C4C’s main point of contact, stepped up to actively manage a new team and the commercialization process. She brought in C4C specialists including patent agent John Tolomei, grant writer Jeanette Ennis, and entrepreneur-in-residence Tom Clement. Clement is one of the region’s top medical device entrepreneurs with more than 25 years of experience in product development engineering and senior management.
Clement and Carricaburu helped Browd and Lutz map a path to commercialization, beginning with establishing intellectual property. C4C filed two provisional patents and one international patent, and is planning licensing options. A $100,000 Wallace H. Coulter Foundation Grant awarded in early 2010 is funding initial shunt design. Additional project funding includes $150,000 from Washington State’s Life Sciences Discovery Fund, a $50,000 research gift from the Washington Research Foundation, a $50,000 C4C Commercialization Gap Fund Award, and $10,000 from C4C for critical product development. C4C worked with the team to apply for $1.5 million from the federal Small Business Innovation Research program.
For the past year, Carricaburu has convened a weekly meeting with an expanded team, including UW experts and consultants from the community, to plan next steps in device development and commercialization strategy. Collaborators include experienced UW engineers, Peter Kaufmann and Joel Relethford; Chris Porter, a commercialization consultant with the Washington Biotechnology and Biomedical Association; Dr. Ida Washington, a clinical associate professor of Comparative Medicine; and Brian Cleary, a regulatory consultant and experienced biomedical entrepreneur. Paula Kim, a UW Foster School MBA student funded by an ITHS Fellowship through C4C, joined the team to draft a business plan, and recruited fellow students Daniel Butts, Erik Feest, and Jennifer Davis to enter it into the 2011 UW Business Plan Competition.
In the US alone, newborns and children under age two undergo 15,000 initial shunt placements annually. Children and adults who suffer head trauma account for 24,000 new placements. Other causes of hydrocephalus, such as brain tumor surgery and stroke, or conditions affecting the elderly, total about 27,000 new placements for a total of 78,000 major, risky surgeries every year. Another 38,000 surgeries replace failed shunts. Approximately 440,000 procedures are performed annually in the US to externally drain CSF from the cerebral ventricles or lumbar subdural space. The overall domestic need for external devices is estimated to be $40 million per year and $200 million for internal devices.
Spin-off Company Launched
With C4C, Browd and Lutz proceeded to found a company, Aqueduct Neurosciences, to develop and market the device. The company’s name was derived from a small passageway between the brain’s third and fourth ventricle. Aqueduct is beginning to meet with investors to raise outside capital.
“The Aqueduct endeavor started with a well-defined market and an identified patient group with a real need. It attracted a team of people who immediately established a strong rapport that accelerated the commercialization process,” Clement said. “Every element for a successful launch is present.”
Browd and Lutz confer daily by exchanging emails, often in the early hours of the morning. C4C staff members joke that emails rarely hit their inboxes during normal hours.
“This is our passion. We’re invested emotionally and have put enormous hours of work into this,” Lutz said. “There needs to be a paradigm shift in the way hydrocephalus is treated.”
“For me it’s incredibly gratifying that the University finds this work valuable and provides such exceptional support, knowing that success will improve children’s and family’s lives.” Browd said. “It’s disruptive technology. Most physicians don’t have the opportunity to take an idea like this and implement it.”